Assisted Reproductive Technology (ART) helps to create an embryo by bypassing common factors that often cause fertility problems.

An ART procedure known as in vitro fertilization (IVF) involves retrieval of fluid from a woman’s egg-containing ovarian follicles. The fluid is microscopically examined for an egg by the embryologist. The retrieved eggs are combined with your partner's or donor's sperm in the laboratory to create an embryo, which is then transferred to the womb.

Typically, Assisted Reproductive Technologies use medications such as Gonal-f® (follitropin alfa for injection) that supplement or replace a woman's natural supply of FSH hormones to help mature eggs by stimulating the growth of multiple egg-containing follicles in the ovary. Other medications may also be used to control the timing of the reproductive cycle.

have a tumor in your female organs, including your ovaries, breast, or uterus

have a tumor in your brain, such as a tumor in your pituitary or hypothalamus

have abnormal bleeding from your uterus or vagina

have ovarian cysts or large ovaries, not due to polycystic ovary syndrome (PCOS)

Before you use Gonal-f® RFF* Redi-ject™, tell your healthcare provider if you:

have or have had asthma

have been told by a healthcare provider that you have an increased risk for blood clots (thrombosis)

have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot (thrombosis)

have had abdominal surgery

have had twisting of your ovary (ovarian torsion)

had or have a cyst on your ovary

have polycystic ovarian disease

have any other medical conditions

are breastfeeding or plan to breastfeed

are taking any other prescription or over-the-counter medicines, vitamins, and herbal supplements

Gonal-f® RFF* Redi-ject™may cause serious side effects, including:

severe allergic reactions in women who have used Gonal-f®, Gonal-f® RFF, or Gonal-f® RFF Redi-ject™ in the past. New allergic reactions can occur immediately after an injection. Severe allergic reaction may lead to death. If you have any of the following symptoms of a severe allergic reaction, stop using Gonal-f® RFF Redi-ject™ and go to the hospital right away:

shortness of breath

swelling of your face

itchy, red bumps or rash on your skin (hives)

ovaries that are too large; symptoms of bloating or pain in your lower stomach (pelvic) area.

ovarian hyperstimulation syndrome (OHSS); a serious medical condition that can happen when your ovaries produce too many eggs (overstimulated). OHSS can cause fluid to suddenly build up in the area of your stomach, chest, and heart, and can cause blood clots to form. In rare cases OHSS has caused death. OHSS may also happen after you stop using Gonal-f® RFF Redi-ject™. Stop using Gonal-f® RFF Redi-ject™ and call your healthcare provider right away if you have symptoms of OHSS, including:

twisting (torsion) of your ovary if you already have certain conditions such as ovarian cysts, OHSS, pregnancy and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.

pregnancy with more than 1 baby and birth of multiple babies; Having a pregnancy and giving birth to multiple babies at a time increases the health risk for you and your babies. Your healthcare provider should tell you about your chances of multiple births.

birth defects in a baby born after an ART cycle (IVF or ICSI). Your chances of having a baby with birth defects may increase depending on:

your age

certain sperm problems

your genetic background and that of your partner

a pregnancy with more than 1 baby at a time

ectopic pregnancy (pregnancy outside your womb). Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems.

miscarriage. Your chance of loss of an early pregnancy may be increased if you had difficulty becoming pregnant.

tumors of the ovary. If you have used fertility medicines like Gonal-f® RFF Redi-ject™ (follitropin alfa injection) before to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

The most common side effects of Gonal-f® RFF* Redi-ject™ include:

headache

stomach pain

stomach bloating

bruising at the injection site

nausea

These are not all the possible side effects of Gonal-f® RFF Redi-ject™. For more information, call your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Do not share your Gonal-f® RFF Redi-ject™ and needles with another person. You may give another person an infection or get an infection from them.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Also read the Gonal-f® RFF* Redi-ject™ “Instructions for Use” that comes with Pen for information about the correct use of Gonal-f® RFF Redi-ject™ and follow all training and instruction provided by your healthcare provider.